Shares in South African pharmaceutical company Aspen Pharmacare were up more than 5,5% in early trade on Monday following an announcement that it is to supply the United States government with generic anti-retrovirals (ARVs).
At 9.21am, Aspen was quoted at R19, up one rand or 5,56% from Friday’s close of R18. On Friday, the share hit a lifetime high of R18,25.
The company said on Monday that it has received approval from the US Federal Drug Administration (FDA) for its multimillion-rand oral solid dosage facility in Port Elizabeth, which will initially manufacture combination-pack generic ARVs as soon as the product receives FDA registration.
Earlier this year, the US government announced the establishment of the US president’s Emergency Plan for Aids Relief (Pepfar) initiative, which pledged $15-billion to assist developing countries as they address the HIV/Aids crisis over the next five years.
This initiative also made provision for manufacturers to obtain an expedited FDA review and approval of their products, while ensuring that the products are safe, effective and meet the stringent quality standards of the FDA.
Aspen group CEO Stephen Saad said: “We have applied to the FDA for an expedited review and Aspen is subsequently undergoing a rigorous process to secure FDA registration of Lamivudine 150mg/Zidovudine 300mg and Nevirapine 200mg co-packaged tablets, a combination-pack ARV.
“The FDA’s findings on the facility, of no outstanding issues [termed 483s], recognises Aspen as being the first African manufacturer and the first developing nation to receive approval for their facility to supply a combination-pack generic ARV to the Pepfar programme.”
Aspen pioneered the formulation and development of generic ARVs under voluntary licences from the originators. It has six registered generic ARVs, some of which are being manufactured at its oral solid dosage facility. — I-Net Bridge